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This study aims to test the safety, efficacy and potential mechanism of action of the SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 2 aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8 week fall URI season. Subjects will use an active device (positive expiratory pressure and 128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8 weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community acquired viral URIs. Subjects will use active or sham device as above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SinuSonic Device | Experimental | SinuSonic device used for 1 min three times a day for 8 weeks. |
|
| Sham | Sham Comparator | Sham SinuSonic device used for 1 min three times a day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SinuSonic Device | Device | A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Symptoms Score (TSS) | The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom. The TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness. The severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms) Minimum score=0; maximum score=27. | 60 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinus Center - Medical Univesity of South Carolina | Charleston | South Carolina | 29425 | United States |
Not Applicable. The investigators plan to publish this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | SinuSonic Device | SinuSonic device used for 1 min three times a day for 8 weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. |
| FG001 | Sham | Sham SinuSonic device used for 1 min three times a day for 8 weeks. Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SinuSonic Device | SinuSonic device used for 1 min three times a day for 8 weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. |
| BG001 | Sham |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Symptoms Score (TSS) | The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom. The TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness. The severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms) Minimum score=0; maximum score=27. | Posted | Mean | Standard Deviation | scores | 60 Days |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SinuSonic Device | SinuSonic device used for 1 min three times a day for 8 weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Department of Otolaryngology - Head and Neck Surgery | (843)792-1356 | nguyensh@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 | Sep 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| Sham SinuSonic Device | Device | Sham positive expiratory pressure intervention using the SinuSonic Device. |
|
|
Sham SinuSonic device used for 1 min three times a day for 8 weeks.
Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Sham SinuSonic device used for 1 min three times a day for 8 weeks. Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device. |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 1 |
| 39 |
| EG001 | Sham | Sham SinuSonic device used for 1 min three times a day for 8 weeks. Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device. | 0 | 13 | 0 | 13 | 0 | 13 |
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